SERVICES

• About U.S. Validation Services, LLC

  

  With more than 30 years of industry experience, we excel in delivering pragmatic and budget-friendly solutions that guarantee the validation of your facilities, utility systems, computerized systems, software, and equipment, all while enhancing FDA compliance.
  Our seasoned team, with expertise in GMP-regulated industries, will guide you through the validation process for your facilities, utility systems, and equipment.

• Validation Planning and Audit

  • Validation Program Auditing and Optimization
  • Policy, SOP, and Validation Master Plan Development
  • Validation Project Management
  • Protocol Development and Execution (IQ, OQ, PQ)
  • Deviation Management and CAPA Implementation

• Risk-Based Validation Services

  • Risk Assessments and Mitigation Planning
  • Compliance and Readiness Assessments
  • Validation Master Plan (VMP) Development
  • Validation Project Management
  • GAP Analysis and Remediation Strategies
  • Development of Validation Lifecycle Documentation (Plans, Protocols, Reports, SOPs)
  • Equipment and System Qualification: FAT, SAT, IQ, OQ, PQ

• Computerized Systems Validation

  • Software Vendor Audits
  • Validation Master Planning
  • User and Functional Requirements Specifications
  • Validation Protocol Development and Execution

• 21 CFR Part 11 - Electronic Records & Signatures

  • Compliance Assessments
  • Gap Analysis and Remediation Planning

• Calibration Program Management

  • Metrology Program Auditing and Optimization
  • Calibration Policies and SOP Development
  • Review and Preparation of Calibration Procedures